Establishing Traceability Chain of Infusion and Perfusor Pumps Using Legal Metrology Procedures in Bosnia and Herzegovina

Abstract

Establishing the traceability chain of measurements for medical devices (MDs) commonly used in everyday patient treatment was the main objective of this paper. This should directly ensure that through periodical calibrations of etalons and independent inspection procedure of MDs according to international standards, safe and accurate diagnosis and treatment can be created. This study is designed to cover 850 perfusors and 700 infusion pumps used in public and private healthcare institutions, during a period of one year. Testing procedures were carried out according to international standards and legal metrology legislative procedures in Bosnia and Herzegovina. The results show that the average measurement uncertainty of infusion pump is 0.9 ml, while for perfusor pump is 0.7 ml. These obtained results combined with other relevant documents, references and competences create the traceability chain. Additionally, as consequence cost benefits analysis proved yearly savings of 50% if healthcare institutions follow legal metrology procedures compared with unnecessary manufactures attests. Research emphasizes importance of establishing traceability chain in protection of public health. Results offered also implications for adequacy of etalon calibration and preventive maintenance performed on MDs. Based on collected measurement data, web-based application with database of infusion and perfusor pumps used in healthcare institutions in Bosnia and Herzegovina was created.